Experimental immune cell combo targets Drug-Resistant lung cancer
NCT ID NCT07330050
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether a new immune cell treatment called WAST cells, combined with the chemotherapy drug docetaxel, can shrink tumors or slow disease in people with advanced non-small cell lung cancer that has stopped responding to PD-1 inhibitors. The study plans to enroll 31 participants and will measure how many patients respond to the treatment, as well as how long they live without the cancer getting worse. The goal is to find a new option for patients who have run out of effective therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WAST cells (a type of immune cell) and docetaxel (chemotherapy)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced lung cancer that has stopped responding to standard immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 31 participants, so results may not apply to everyone. The treatment involves chemotherapy, which has known side effects like fatigue and infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * At screening, patients must meet the following diagnostic and treatment criteria: 1) Histologically or cytologically confirmed NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months; * At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening; * Adequate bone marrow reserve at screening, defined as: Absolute neutrophil count (ANC) \>1.5×10⁹/L; Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥100g/L; * Adequate organ function at screening, meeting the following criteria: Aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 ULN if due to tumor infiltration); Alanine aminotransferase (ALT) ≤2.5 times ULN (≤5 ULN if due to tumor infiltration); Total serum bilirubin ≤1.5 times ULN (≤3 ULN if due to tumor infiltration); Serum creatinine (Scr) ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; Minimum lung reserve level, defined as ≤Grade 1 dyspnea and oxygen saturation \>91% without supplemental oxygen; International Normalized Ratio (INR) ≤1.5 times ULN, and activated partial thromboplastin time (APTT) ≤1.5 times ULN; * Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment. Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic CNS metastases, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible); * History of CNS disorders prior to screening, such as epilepsy, cerebrovascular ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes, psychiatric disorders, or any autoimmune diseases affecting the CNS; * Received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening, and deemed unsuitable for enrollment by the investigator; * Discontinued systemic corticosteroid therapy less than 72 hours before cell infusion; however, physiological replacement doses of steroids (e.g., prednisone \<10 mg/day or equivalent) are allowed; * Any history of adoptive cell therapy prior to screening; * History of organ/tissue transplantation prior to screening; * Known active systemic autoimmune diseases under treatment prior to screening; * At screening, meets any of the following criteria: Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive; Hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive, with HBV-DNA copy numbers above the lower limit of quantification; Hepatitis C antibody (HCV-Ab) positive; Treponema pallidum antibody (TP-Ab) positive; HIV antibody test positive; EBV-DNA, CMV-DNA copy numbers above the lower limit of quantification; * Undergone major surgery within 4 weeks prior to screening and deemed unsuitable for enrollment by the investigator; * History of other malignancies within the past 2 years (except successfully treated non-melanoma skin cancer or in situ carcinoma); * At screening, meets any of the following cardiac conditions: Left ventricular ejection fraction (LVEF) ≤50% (by ECHO); New York Heart Association (NYHA) class III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment; Myocardial infarction or cardiac surgery within 12 months prior to cell infusion; Clinically significant valvular heart disease; * Tumor involvement of the atrium or ventricle at screening; * History of pulmonary interstitial fibrosis or severe chronic obstructive pulmonary disease (COPD); * Presence of clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., bowel obstruction or vascular compression) at screening; * Active bleeding at screening; * History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening; * Vaccinated with live vaccines within 6 weeks prior to screening; * Active infection requiring treatment at screening; * Participation in another interventional clinical study within 4 weeks prior to screening;
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for NSCLC (non-small cell lung cancer) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- Can a targeted pill after surgery keep early lung cancer from returning?
- Can a new immune drug outsmart Hard-to-Treat tumors?
- Can a pill plus immunotherapy and targeted radiation shrink lung tumors before surgery?
- Can a targeted drug combo boost chemoradiation in EGFR-Positive lung cancer?